After nabbing an FDA approval last summer for its T-cell lymphoma treatment Lymphir, Citius Oncology is eyeing strategic alternatives.
The company, a subsidiary of Citius Pharmaceuticals, is exploring “all avenues” to boost its strategic positioning, which could include partnerships, mergers or acquisitions, licensing, joint ventures or other transactions, the company said Monday. The New Jersey biotech has tapped Jefferies to assist in the process.
“As we prepare to launch our first cancer therapy, now is an opportune time to review options that would be in the best interests of patients and shareholders," CEO Leonard Mazur said in a company press release. "Our goal is to deliver value to shareholders by making a meaningful impact in the oncology space."
Citius is “committed” to commercializing Lymphir, which was approved to treat patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) who have tried at least one prior systemic therapy. The August nod made for the first drug in the indication that specifically targets the interleukin-2 (IL-2) receptor found on malignant T-cells and regulatory T-cells (Tregs).
The company laid out its launch plans further in a Tuesday update. Citius is looking to make the medicine available to patients over the first half of this year and has made “significant progress to finalize our manufacturing, marketing, reimbursement and sales efforts,” Mazur said.
Already initiated launch preparations include a core marketing campaign to raise awareness among healthcare providers, a patient assistance program and patient services center, targeted education programs and commercial supply agreements with contract manufacturers. The drugmaker is still working with payers to ensure reimbursement pathways.
Outside of working toward significant U.S. market penetration, the company is eyeing “additional growth opportunities” including expanded indications and exploring its potential in combinations. Talks are already underway for licensing partnerships in key international markets, Mazur added.
Lymphir is Citius’ first FDA-approved product and is the second coming of Eisai’s Ontak, which was pulled from the market in 2014 due to manufacturing issues. Eisai made a more purified version of the med and sold its rights outside of Asia to Dr. Reddy’s Laboratories, which in turn sold the treatment to Citius in 2021. The deal gave Dr. Reddy’s $40 million upfront, with a further $40 million upon FDA approval.
Citius finally pushed the drug over the FDA finish line after a prior complete response letter in 2023, when the agency asked for extra product testing but did not flag any efficacy or safety issues. The company puts the initial market for the drug at more than $400 million and notes that it is “underserved” by existing therapies, Citius said in its recent release.
Elsewhere, parent company Citius Pharmaceuticals is looking to figure out the next steps for its antibiotic lock solution Mino-Lok, which is designed to salvage catheters in patients with catheter-related bloodstream infections, after meeting its endpoints in a phase 3 trial in 2023.
Editor's Note: The story was updated Jan. 7 to include Citius' launch preparation update for Lymphir.